Linvoseltamab shows improved outcomes versus real-world standard of care in relapsed/refractory multiple myeloma

This analysis combined data from the LINKER-MM1 Phase 1/2 study cohort (N=105) with an international external control arm (N=203) of real-world standard-of-care patients. All patients had relapsed/refractory multiple myeloma and were triple-class exposed with ≥3 prior lines of therapy or triple-class refractory. The intervention was linvoseltamab 200 mg, compared against real-world International Myeloma Working Group standard-of-care treatments.

Linvoseltamab was associated with improved outcomes across multiple endpoints. The objective response rate was higher with linvoseltamab (weighted odds ratio 3.0, 95% CI: 1.9-4.1). Median progression-free survival was longer (weighted hazard ratio 0.33, 95% CI: 0.28-0.40), as was time to next treatment (weighted HR 0.34, 95% CI: 0.29-0.44). Overall survival also favored linvoseltamab (weighted HR 0.72, 95% CI: 0.58-0.98).

Safety and tolerability data were not reported in this analysis. Key limitations include the use of an external control arm based on chart reviews, which introduces potential confounding despite statistical adjustment using inverse probability of treatment weighting. The study design was not randomized, and the external control patients came from different clinical settings.

These findings suggest linvoseltamab may offer clinical benefit in this heavily pretreated population, but the evidence comes from a non-randomized comparison with methodological constraints. The results highlight the need for randomized controlled trials to establish linvoseltamab's efficacy and safety profile definitively before clinical application.